NCT02860377

Brief Summary

Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

August 3, 2016

Last Update Submit

January 27, 2020

Conditions

Anesthesia, General

Keywords

emergence agitationemergence timepediatric

Outcome Measures

Primary Outcomes (2)

  • Emergence time

    time from discontinuation of anesthetics to extubation

    During 1 hour after operation

  • Incidence of emergence delirium (ED)

    The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of \>12 or Watcha scale over 3.

    During 30 minutes after PACU admission

Secondary Outcomes (4)

  • peak PAED scale

    During 30 minutes after PACU admission

  • peak Watcha scale

    During 30 minutes after PACU admission

  • eye opening or purposeful movement time

    During 1 hour after operation

  • BIS over 60

    During 1 hour after operation

Other Outcomes (2)

  • peak FLACC score

    During 30 minutes after PACU admission

  • The amount of analgesic/anesthetic consumption at PACU/ward

    During 1 hour at PACU

Study Arms (2)

stranger's voice

ACTIVE COMPARATOR

At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.

Procedure: recorded stranger's voice

maternal voice

EXPERIMENTAL

At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.

Procedure: recorded maternal voice

Interventions

recorded maternal voicePROCEDURE

A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences. " OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. " At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.

maternal voice
recorded stranger's voicePROCEDURE

A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences. " OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. "

stranger's voice

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive an operation under general anesthesia

You may not qualify if:

  • ASA PS III or IV
  • with developmental delay or neurological diseases associated with symptoms of agitation
  • refusal of consent
  • with developmental delay
  • with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Eugene Kim, MD

    Daegu Catholic University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 9, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

KR(1)